Remote Director of Biostatistics & Clinical Strategy

Oruka Therapeutics Inc; Boston (MA); Hybrid; USD 213,000 - 240,000; Full time

Benefits offered by this job

Competitive salary & benefits

Startup culture

Professional growth opportunities

Inclusive team environment

Job summary

Oruka Therapeutics Inc. seeks a Director of Biostatistics to provide statistical leadership across clinical programs and to guide study design, SAPs, and regulatory submissions for multiple trials from Phase I to IV.

The ideal candidate has a PhD or equivalent, extensive experience in immunology-related trials, and strong SAS/R expertise. This remote/hybrid role offers collaboration across functions and a competitive package.

Qualifications

• PhD in Biostatistics, Statistics, or a related field with 7+ years of experience in clinical trials, or a Masters degree with 10+ years of experience.
• Strong, up-to-date expertise/knowledge of statistical methodologies related to areas such as clinical trial design, statistical modeling and analysis.
• Proven capability to provide statistical leadership to cross-functional teams, exercise independent judgement and oversee junior statisticians.
• Familiarity in the design, data capture, and analysis of clinical trials with potentially high placebo response.
• Experience in Immunology and Inflammation is highly desirable.
• Knowledge of FDA/EMA regulations, ICH-GCP guidelines, and statistical submission requirements.
• Expertise in CDISC standards, including ADaM requirements.
• Advanced proficiency of SAS; knowledge of R or similar language a plus.
• Strong organizational and time management skills; ability to prioritize multiple deliverables.
• Excellent communication, leadership, and analytical skills.
• Demonstrated ability to work effectively in a dynamic, cross-functional, fast-paced team environment.

Responsibilities

• Lead statistical strategy for clinical development programs, including study design, protocol development, and analysis planning with cross-functional teams.
• Plan and track biostatistics timeline, deliverables, and resources, communicating risks and constraints.
• Independently author or review protocols, SAPs, CSRs, publications, and study documents.
• Provide statistical input for data management and programming deliverables to ensure alignment with objectives.
• Develop statistical programs to support ad-hoc analyses, manuscripts, and presentations; review scientific reports.
• Write statistical sections of regulatory documents and support regulatory strategy.
• Participate in CRO selection and oversight within area of responsibility.
• Ensure compliance with SOPs, ICH GCP guidelines, and regulatory standards.

Skills

Statistical leadership

Clinical trial design

Cross-functional collaboration

Regulatory submission support

SAS programming

R programming

ICH-GCP knowledge

Education

PhD in Biostatistics or related

Master's in Biostatistics or related

Tools

SAS

R

Job description

Oruka Therapeutics Inc. seeks a Director of Biostatistics to provide statistical leadership across clinical programs and to guide study design, SAPs, and regulatory submissions for multiple trials from Phase I to IV.

The ideal candidate has a PhD or equivalent, extensive experience in immunology-related trials, and strong SAS/R expertise. This remote/hybrid role offers collaboration across functions and a competitive package.